To Evaluate if Wide Blood Sugar Fluctuations Lead to Injury of Heart Function and Heart Nerves



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:8/29/2018
Start Date:May 2010
End Date:August 2016

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Cardiac Autonomic Neuropathy and Myocardial Dysfunction in Type 1 Diabetes

This proposal will test if, in patients with type 1 diabetes, wide blood glucose fluctuations
lead to the injury to heart nerves , called cardiac autonomic neuropathy (CAN), and to
impaired heart contractile (pumping) function and heart failure. It will also evaluate the
natural history of heart failure and enhanced cardiac risk in patients with type 1 diabetes
in the current standard of diabetes care.


Inclusion/Exclusion Criteria:

- Male or female between the ages 18-65, with type 1 diabetes of 5-10 years duration who
are free of complications and age-and-sex-matched healthy control volunteers.

- Hemoglobin A1c greater than 7 %. (For Type 1 diabetics)

- If you are a woman of childbearing potential you must agree to use an acceptable birth
control method throughout the duration of the study. The methods of birth control that
you can use are: Oral contraceptives (birth control pill), IUD or a barrier method
(e.g. diaphragm or condom with spermicide).

- You should have no history of any cardiovascular disease including any form of
coronary artery disease, congestive heart failure, known arrhythmias (irregular heart
beats), valvular disease or high blood pressure.

- If you have any pacemaker or ICD, if you have any metallic foreign body such as
surgical implants or clips or foreign bodies in the eye or orbits, wearing medication
patches containing foil, or any other metal in the body or if you are claustrophobic
you cannot participate in this study.

- You should be free of any diabetic complications (e.g. nephropathy or kidney damage,
retinopathy or eye damage), have no history of previous kidney, pancreas or cardiac
transplantation, any other severe chronic illness that has neuropathy (numbness,
burning or tingling) and/or neurologic disease as a recognized complication (e.g.
Parkinson's disease, epilepsy), or any other serious medical conditions that may
shorten life span (e.g. disabling stroke, Chronic Obstructive Pulmonary Disease).

- You should be free of any malignancy other than basal cell skin cancer.

- No history of alcohol abuse.

- You should not use any agents or drugs that interfere with the imaging techniques
described below.

- You must be able to cooperate with the test protocols that are described below and be
willing to sign this consent form.

Inclusion for Control group:

- BMI <30

- If female, must not be pregnant or nursing

- Normal blood pressure

- Normal labs-(glucose and lipids)
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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